MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema

Официальное название

A Multicenter, Open-label, Dose Escalation Study Assessing the Safety and Treatment Effects of MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema

Обзор

This is an open label dose-escalation study to evaluate the safety and treatment benefits of MS-553 in treatment-naive diabetic retinopathy patients with central involved macular edema. Fifteen subjects with diabetic macular edema will be enrolled into each of three dose cohorts and will receive oral administration of MS-553 for 8 weeks.

Вмешательства

• Препарат MS-553
  MS-553

Первичные конечные точки

• Treatment-emergent adverse events [Срок оценки: Baseline to Day 56]

Вторичные конечные точки (5)

• Mean change in the central retina subfield thickness (CRT) [Срок оценки: Baseline to Day 56]
• Mean change in the retinal volume [Срок оценки: Baseline to Day 56]
• Proportion of patients with >20% reduction in CRT [Срок оценки: Baseline to Day 56]
• Proportion of patients with resolution of central involved macular edema [Срок оценки: Baseline to Day 56]
• Average mean change in best corrected visual acuity [Срок оценки: Baseline to Day 56]

Критерии участия

Критерии включения

• Diagnosis of diabetes mellitus (type 1 or type 2) according to ADA or WHO diabetic diagnosis criteria
• Subject has the ability to follow the study instructions and is likely to complete all required study procedures and visits;
• All males and females must consent to pregnancy prevention during the study and qualified measures of birth control. All females of childbearing potential must consent to a pregnancy test before entering the study.
• Presence of central involved macular edema associated with diabetic retinopathy, i.e. diabetic macular edema (DME), as assessed by spectral domain optical coherence tomography (sd-OCT) of the central retina subfield thickness (CRT) at the Screening Visit (Centration must be confirmed by Investigators with signatures);
• Best Corrected Visual Acuity (BCVA) score ≥ 34 letters (approximately 20/200 to 20/20 Snellen equivalent or better) using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity protocol, and assessed at the Screening Visit Visual acuity (VA);
• Confirmation by the investigator that laser photocoagulation and anti-VEGF treatments are either declined by the patients or not needed and can be withheld for at least 3 months after the Screening Visit;
• Ocular media and pupil dilation adequate to permit good quality retinal imaging as assessed at Screening Visit.

Критерии исключения

• Subjects with unstable metabolic or blood pressure control
• Subject with emaciation or obesity at Screening Visit: body mass index (BMI) <18.5kg/m2 or >28kg/m2
• Current use or likely need for medications know to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine / hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol -
• History of myocardial infarction or other cardiac event requiring hospitalization (unstable angina pectoris, etc.), cerebrovascular accident, transient ischemic attack, treatment for acute congestive heart failure or any arrhythmia within 4-months prior to Screening Visit;
• Any situation that may in the opinion of the investigator preclude the safe administration of the study medication, adherence to the scheduled study visits, safe participation in the study or affect the results of the study as assessed at Screening Visit;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• The Second Xiangya Hospital of Central South University — Чанша
• West China Hospital of Sichuan University — Чэнду
• Shanghai General Hospital — Шанхай

Идентификаторы

NCT: NCT04187443 · 2019-001-CN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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